| Primary Device ID | 00842271157997 |
| NIH Device Record Key | d11eecdc-9197-4010-b0a4-4bf0330250f2 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | PressCeramic |
| Version Model Number | PressCeramic LT B3 /4 |
| Catalog Number | 742860 |
| Company DUNS | 002265727 |
| Company Name | SAGEMAX BIOCERAMICS, INC |
| Device Count | 4 |
| DM Exempt | false |
| Pre-market Exempt | false |
| MRI Safety Status | Labeling does not contain MRI Safety Information |
| Human Cell/Tissue Product | false |
| Device Kit | false |
| Device Combination Product | false |
| Single Use | true |
| Lot Batch | true |
| Serial Number | false |
| Manufacturing Date | true |
| Expiration Date | false |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | true |
| OTC Over-The-Counter | false |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00842271157997 [Unit of Use] |
| GS1 | 00842271165558 [Primary] |
| EIH | Powder, Porcelain |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2023-08-29 |
| Device Publish Date | 2023-08-21 |
| 00842271157676 | PressCeramic HT C3 /4 |
| 00842271157669 | PressCeramic HT C2 /4 |
| 00842271157652 | PressCeramic HT C1 /4 |
| 00842271157645 | PressCeramic HT B4 /4 |
| 00842271157638 | PressCeramic HT B3 /4 |
| 00842271157621 | PressCeramic HT B2 /4 |
| 00842271157614 | PressCeramic HT B1 /4 |
| 00842271157607 | PressCeramic HT A4 /4 |
| 00842271157591 | PressCeramic HT A3.5 /4 |
| 00842271157584 | PressCeramic HT A3 /4 |
| 00842271157577 | PressCeramic HT A2 /4 |
| 00842271157560 | PressCeramic HT A1 /4 |
| 00842271158147 | PressCeramic Opal 2 /4 |
| 00842271158130 | PressCeramic Opal 1 /4 |
| 00842271158123 | PressCeramic MO 4 /4 |
| 00842271158116 | PressCeramic MO 3 /4 |
| 00842271158109 | PressCeramic MO 2 /4 |
| 00842271158093 | PressCeramic MO 1 /4 |
| 00842271158086 | PressCeramic MO 0 /4 |
| 00842271158079 | PressCeramic LT D4 /4 |
| 00842271158062 | PressCeramic LT D3 /4 |
| 00842271158055 | PressCeramic LT D2 /4 |
| 00842271158048 | PressCeramic LT C4 /4 |
| 00842271158031 | PressCeramic LT C3 /4 |
| 00842271158024 | PressCeramic LT C2 /4 |
| 00842271158017 | PressCeramic LT C1 /4 |
| 00842271158000 | PressCeramic LT B4 /4 |
| 00842271157997 | PressCeramic LT B3 /4 |
| 00842271157980 | PressCeramic LT B2 /4 |
| 00842271157973 | PressCeramic LT B1 /4 |
| 00842271157966 | PressCeramic LT A4 /4 |
| 00842271157959 | PressCeramic LT A3.5 /4 |
| 00842271157942 | PressCeramic LT A3 /4 |
| 00842271157928 | PressCeramic LT A1 /4 |
| 00842271157911 | PressCeramic LT BL4 /4 |
| 00842271157904 | PressCeramic LT BL3 /4 |
| 00842271157898 | PressCeramic LT BL2 /4 |
| 00842271157881 | PressCeramic LT BL1 /4 |
| 00842271157874 | PressCeramic MT BL4 /4 |
| 00842271157867 | PressCeramic MT BL3 /4 |
| 00842271157850 | PressCeramic MT BL2 /4 |
| 00842271157843 | PressCeramic MT D2 /4 |
| 00842271157836 | PressCeramic MT C2 /4 |
| 00842271157829 | PressCeramic MT C1 /4 |
| 00842271157812 | PressCeramic MT B2 /4 |
| 00842271157805 | PressCeramic MT B1 /4 |
| 00842271157799 | PressCeramic MT A3.5 /4 |
| 00842271157782 | PressCeramic MT A3 /4 |
| 00842271157768 | PressCeramic MT A1 /4 |
| 00842271157751 | PressCeramic HT BL4 /4 |